Brian Coffey Email & Phone Number

Thousand Oaks, Ca, Us

Thousand Oaks, Ca, Us

Thousand Oaks, Ca, Us

Thousand Oaks, Ca, Us

Responsible for leading a team of approx 50 Engineering staff to deliver engineering services to the plant. Programs of respnsibility includeSite Calibration Program.Engineering Planning & Scheduling. Site spare part, warehouse and inventory management program.Site Drawing Office Management. Facilities & Engineering Complince program.

Thousand Oaks, Ca, Us

Responsible for leading the Site Validation Organisation of 30+ people including Managers and Senior Managers .Responsible for providing expert technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardising and improving new and existing equipment.Overall responsibilities to prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards.Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.Develop, maintain, and justify the departments’ budgets.Responsible for recruiting talented staff into the facility and setting standards for their performance.Assure the appropriate level of training is undertaken for all levels of the validation organization which may involve developing training material.Manage the Technical Services projects-provide technical support in introducing equipment, process improvements and new products.Manage the qualification/validation of sterilization equipment and processes directly associated with manufacturingEnsure products and equipment are qualified to the highest standards and that personnel and equipment records meet the requirements of the relevant regulatory agencies.Maintain and foster the broader objectives of the company in the Validation department by promoting the spirit of Leadership Behaviours, Company Values and emphasizing the need for teamwork with all departments.Provide support to QA/PD/RA in the preparation of Process Change Requests and regulatory submissions.SkillsDemonstrated strong people and project management skills with proven ability to define and execute the validation elements of a project from design to routine facility operationCapable of creating a team environment among existing site groups and creating a unified culture within the validation organization.

Thousand Oaks, Ca, Us

Responsible for leading a validation team of ~20 people including people managers.Responsible for providing expert technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardising and improving new and existing equipment.Overall responsibilities to prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards.Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.Develop, maintain, and justify the departments’ budgets.Responsible for recruiting talented staff into the facility and setting standards for their performance.Assure the appropriate level of training is undertaken for all levels of the validation organization which may involve developing training material.Manage the Technical Services projects-provide technical support in introducing equipment, process improvements and new products.Manage the qualification/validation of sterilization equipment and processes directly associated with manufacturingEnsure products and equipment are qualified to the highest standards and that personnel and equipment records meet the requirements of the relevant regulatory agencies.Maintain and foster the broader objectives of the company in the Validation department by promoting the spirit of Leadership Behaviours, Company Values and emphasizing the need for teamwork with all departments.Provide support to QA/PD/RA in the preparation of Process Change Requests and regulatory submissions.SkillsDemonstrated strong people and project management skills with proven ability to define and execute the validation elements of a project from design to routine facility operationCapable of creating a team environment among existing site groups and creating a unified culture within the validation organization.

Thousand Oaks, Ca, Us

Responsibilities: Attract, retain and develop a strong team of engineers to meet the needs of Patient Supply into the futureProvide leadership and tactical direction to the Engineering function supporting all Patient Supply process equipmentManage and report on day to day team activitiesEnsure reliable processes and equipment are developed and maintainedPartner with the maintenance team to ensure maintenance program is executed and adhered toDeliver the maintenance and calibration strategy based on Lean Maintenance principles incorporating modern reliability and maintenance philosophiesProvide leadership and participation in critical investigationsSupport non-conformances and CAPA execution / closureGenerate and present reports and metrics such as System Effectiveness Packs (SEPs)Monitor and improve system performancePartner with global network peers on network initiatives

Thousand Oaks, Ca, Us

Primary Responsibilities, Accountabilities and Decisions Rights. Site technical expert for process & systems.Trend all performance aspects analyze, determine RC & implement CAPA solutions. Day by day process & operation monitoring. Own live line risk assessment & ongoing mitigation projects. Own line, process & equipment improvement projects. Resp for new equipment design in collaboration with Global Eng Tech Authority & PD. Review & approve line procedure changes & change controls. Own line Risk Assessment. Resp for and closely monitor line performance, throughput, NCs, operator performance and competency, maintenance practices, IPCs, CAPAs, equipment problems, correctness of the procedures, lot performance, etc. Monitor equip performance to guidelines. Perform periodical line system evaluations and monitoring. NC investigation Assessments. Resp for training content/execution for mfg and process technicians. ATEC/IMA LIFE/BOC EDWARDS. Stopper Prep and Sterilisation. Lyophilisation. CIP. SIP.

Thousand Oaks, Ca, Us

Ensure the validated state of the systems by reviewing and approving WO’s; reviewing job plans; spare part requirements; evaluate parts replacement; evaluate potential impact on delayed PM’s. Evaluate, plan, and implement solutions for process improvement opportunities.Provide troubleshooting support and technical & equipment related input for complaints investigation. Assist in generation of training materials. Participate in Non-conformance triage as required within the established goal.Responsible for authoring investigation reports such as technical assessments. Monitor and communicate incidents trends.Equipment Requirements and Design Specifications Owner.STERIS/ATEC SIP, CIP, Stopper Prep, Sterilisation.

Thousand Oaks, Ca, Us

Manage Maintenance team in order to support customer requirements in a sterile fill finish processing Suite.Manage and report personnel performance and address performance and ensure 100% compliance to site and regulatory requirements.Review equipment performance of Suite processing equipment and manage continuous improvement projects to improve equipment performance and reliability.Work with manufacturing scheduler/planner to prioritise corrective work requirements for suite processing equipment to minimise downtime.Manage and perform RCFA into equipment failures and identify and implement CAPA’s.Manage and lead site reliability engineers to develop and present maintenance metrics associated with suite processing equipment.Utilisation of Six Sigma tools for continuous improvement in maintenance activities.Responsible for PM compliance and ensuring all tasks are carried out as per site GMP and EH&S requirements. Ensure the PM program is adhered to and that all unscheduled and emergency work is minimised. Carry out and document investigations into safety observations and incidents and identify and implement CAPA’s to prevent recurrence.Carry out and document investigations into quality deviations and identify and implement CAPA’s to prevent recurrence.BOSCH Vial Washer,Tunnel, BOSCH FIller BOSCH Cappers. Compounding. Steridose. Parts Washers.

Asnières Sur Seine, France, Fr

Key member of an Engineering team overseeing the commissioning, calibration, maintenance and reliability of automated plant and equipment including but not limited to Freeze Dryers, Automated Filling Lines, Refrigerated Centrifuges, BSC,s, Autoclaves, Part Preparation Equipment, Processing Equipment, DIW Systems and Utilities. Design User Requirement Specification Documents for new pieces of Fill Finish equipment and liaise with external vendors for quotations and recommendations. Tech Transfer Engineer on a $50Million project where we acquired a new product group from USA. Spent 3 months in USA managing and directing projects. Transferred Fill Finish equipment from the USA to Ireland and re developed Freeze Dry Cycles from the USA site to Ireland.Cozooli Filling Equipment, Gentinge Autoclaves, ROTA Filling Equipment, Flexicon Filling Equipment, Hull, Christ & Vertis Freeze Dryers. Rota Vap.

Bray, Co. Wicklow, Ie

Kenilworth, New Jersey, Us

H-Dip Business Management, Business/Managerial Economics

Diploma, Project Management

Mechanical Craft Trade, Industrial Mechanics And Maintenance Technology

Maintenance And Facilities Management